Cloudbreak Pharma Inc. (Stock Code: 2592) Announces US FDA IND Approval for CBT-199

Bulletin Express

Feb 16

Cloudbreak Pharma Inc. (Stock Code: 2592) released a voluntary announcement stating that the investigational new drug (IND) application for CBT-199, filed on 12 December 2025 with the United States Food and Drug Administration (FDA), has become effective with no clinical hold imposed. This status confers Safe-to-Proceed clearance, allowing the commencement of Phase 2 clinical trials.

According to the announcement, CBT-199 is a novel topical ophthalmic emulsion intended for the treatment of presbyopia. It contains a parasympathomimetic miotic agent formulated in a non-aqueous platform designed to create a pinhole effect through pupil constriction, improving near vision. The water-free formulation aims to enhance stability of the active ingredient and support a consumer-friendly multi-dose presentation with a long shelf life. Pre-clinical animal studies began in 2023 to evaluate its safety and tolerability.

The announcement reiterates that there is no guarantee CBT-199 or any other candidate will be successfully developed or commercialized. Caution is advised when dealing in the shares of Cloudbreak Pharma Inc.

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(Stock Code: 2592) Announces US FDA IND Approval for CBT-199\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1053168898\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/ed558ed0402cbe7d1ef4d150458f2b2e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Bulletin Express </p>\n<p class=\"h-time\">2026-02-16 12:41</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Cloudbreak Pharma Inc. (Stock Code: 2592) released a voluntary announcement stating that the investigational new drug (IND) application for CBT-199, filed on 12 December 2025 with the United States Food and Drug Administration (FDA), has become effective with no clinical hold imposed. 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